510(k) K963136

PACER MODEL 100 INFUSION CONTROLLER by Health Watch, Inc. — Product Code LDR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 10, 1997
Date Received
August 13, 1996
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Controller, Infusion, Intravascular, Electronic
Device Class
Class II
Regulation Number
880.5725
Review Panel
HO
Submission Type